Evidence map›Paper›PMID 36759648›Full record

Trial reportScientific reports2023

Phase II dose titration study of regorafenib in progressive unresectable metastatic colorectal cancer.

Takeshi Kato, Toshihiro Kudo, Yoshinori Kagawa, Kohei Murata, Hirofumi Ota, Shingo Noura, Junichi Hasegawa, Hiroshi Tamagawa, Katsuya Ohta, Masakazu Ikenaga and 12 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Scientific reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.0field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 8 institutions in 1 country.

Takeshi KatoDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Toshihiro KudoDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan. tkudo@mc.pref.osaka.jp.ORCID 0000-0003-3584-6375
Yoshinori KagawaDepartment of Colorectal Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Kohei MurataDepartment of Colorectal Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Hirofumi OtaDepartment of Digestive Surgery, Ikeda City Hospital, Ikeda, Japan.
Shingo NouraDepartment of Surgery, Osaka Rosai Hospital, Sakai, Japan.
Junichi HasegawaDepartment of Surgery, Osaka Rosai Hospital, Sakai, Japan.
Hiroshi TamagawaDepartment of Surgery, Otemae Hospital, Osaka, Japan.
Katsuya OhtaDepartment of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan.
Masakazu IkenagaDepartment of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan.
Susumu MiyazakiDepartment of Surgery, Osaka General Medical Center, Osaka, Japan.
Takamichi KomoriDepartment of Surgery, Osaka General Medical Center, Osaka, Japan.
Mamoru UemuraDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Junichi NishimuraDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Taishi HataDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Chu MatsudaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Taroh SatohDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.
Tsunekazu MizushimaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Yuko OhnoDepartment of Mathematical Health Science, Graduate School of Medicine, Osaka University, Suita, Japan.
Hirofumi YamamotoDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Yuichiro DokiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Hidetoshi EguchiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
The University of Osaka · JPKansai Rosai Hospital · JPOsaka City General Hospital · JPOsaka Prefectural Medical Center · JPOsaka Rosai Hospital · JPIkeda Municipal Hospital · JPOsaka National Hospital · JPOtemae Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Regorafenib has shown significant survival benefit as a salvage therapy for colorectal cancer; however, its starting dose has been controversial in recent studies. Therefore, we conducted a prospective study on the efficacy and safety of the dose reduction of regorafenib to 120 mg. Patients received 120 mg regorafenib once per day for 3 weeks, followed by a 1-week off-treatment period. The primary endpoint was the investigator-assessed disease control rate (DCR). Sixty patients were registered, and the DCR was 38.3% with a median progression-free survival of 2.5 months (95% confidence interval [CI] 1.9-3.7) and median overall survival of 10.0 months (95% CI 6.9-15.2). Common grade 3-4 adverse events were hand-foot skin reaction and hypertension (20.0% each). The results of administration of 120 mg regorafenib as the starting dose are consistent with reports from prior phase III trials, which used starting doses of 160 mg. This lower initiating dose of regorafenib may be beneficial to certain patient populations. This clinical trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR number UMIN000018968, registration date: 10/09/2015).

Indexed as

Colonic NeoplasmsColorectal NeoplasmsRectal NeoplasmsHumansPhenylurea CompoundsProspective StudiesPyridinesPhenylurea CompoundsPyridinesregorafenib

Identifiers

PMID36759648
PMCPMC9911606
OpenAlexW4319741957

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.